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CTRI Number  CTRI/2022/10/046369 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 10/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To Evaluate the usefulness of a parameter called perfusion index in predicting the success of ultrasound guided nerve block for surgery 
Scientific Title of Study   Evaluation of perfusion index as an early objective tool to predict the success of ultrasound guided costoclavicular block 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Premkumar D 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and PGIMSR 
Address  Department of Anaesthesiology, First floor,B block, ESIC medical College and PGIMSR

Chennai
TAMIL NADU
600078
India 
Phone    
Fax    
Email  d.premkumar.1993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Premkumar D 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and PGIMSR 
Address  Department of Anaesthesiology, First floor,B block, ESIC medical College and PGIMSR

Chennai
TAMIL NADU
600078
India 
Phone    
Fax    
Email  d.premkumar.1993@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Premkumar D 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and PGIMSR 
Address  Department of Anaesthesiology, First floor,B block, ESIC medical College and PGIMSR

Chennai
TAMIL NADU
600078
India 
Phone    
Fax    
Email  d.premkumar.1993@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical college and PGIMSR 
 
Primary Sponsor  
Name  Premkumar D 
Address  Department of Anaesthesiology, First floor,B block, ESIC medical College and PGIMSR ,Kk Nagar,Chennai 600037 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Premkumar D  ESIC Medical College & PGIMSR  Department of Anaesthesiology, First floor,B block, ESIC medical College and PGIMSR,k.k.nagar
Chennai
TAMIL NADU 
9566220405

d.premkumar.1993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Perfusion Index  Perfusion index will be measured using the monitor Truskan S500. Perfusion Index will be measured using pulse oximetry applied on the index finger. Perfusion Index will be recorded at baseline (before local anaesthetic administration), at every 2 minutes till 10 minutes and then every 5 minutes till 30 minutes.The total duration of the intervention is 30 minutes. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologist (ASA) class I and II.
2.BMI less than 29.9 Kg/M2.
3.Patients undergoing Upper limb surgeries 
 
ExclusionCriteria 
Details  1.Patient refusal to regional anaesthesia.
2.Anatomical abnormality at the site
3.Local infection at the site of puncture.
4.Patients having any coagulation abnormality
5.Patient having a known allergy to study drugs
6.Contralateral phrenic nerve palsy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To test the Predictive accuracy of Perfusion index as an objective tool for the success of costoclavicular block.  Perfusion index values will be recorded every 2 minutes till 10 mins and then every 5 mins till 30 mins of the block. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the variations in Perfusion index value between successful and unsuccessful block.  Perfusion index values will be recorded every 2 minutes till 10 mins and then every 5 mins till 30 mins of the block.Data will be recorded for both successful and unsuccessful block , the variations of the perfusion index from the baseline will be measured. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Brachial plexus block is a popular and widely employed regional nerve block technique for perioperative anaesthesia and analgesia for surgery of the upper extremity. The costoclavicular brachial plexus block (CCB) is a recently introduced infraclavicular approach that targets three cords located lateral to the axillary artery in the costoclavicular space .Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered, while maintaining a consistent anatomical relationship with each other In addition, the costoclavicular space is considered a retrograde channel to the supraclavicular area, enabling reliable anaesthesia, including anaesthesia to the suprascapular nerve during shoulder surgery and providing additional stability in catheter placement for a continuous brachial plexus block .Because of these anatomical advantages, the CCB is emerging as a promising infraclavicular approach. Lignocaine 1% and Bupivacaine 0.5% mixture is used frequently for costoclavicular nerve block as it has early onset due to lignocaine and long duration of action due to bupivacaine from 3 to 6 h. The success of the peripheral nerve block is determined by the evaluation of sensory and motor functions. But these conventional methods (Pin-prick test and Modified Bromage Scale) are subjective, and they depend on patient’s cooperation.Many objective methods like laser doppler perfusion imager (LDPI) ,skin electrical resistance, thermographic temperature measurement have been developed to evaluate block success, these are expensive and require special devices Perfusion index (PI) is a simple, objective and noninvasive monitoring modality. It is the ratio of Pulsatile flow to Non pulsatile flow ,Pulsatile flow increases with sympathetic block in the nerve block ,hence perfusion index increases in a successful block .present study aims to evaluate the Change in perfusion index as an early objective tool to predict successful Ultrasonography guided costoclavicular block in patients posted for upper limb surgeries

 
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